← Back to Search

Nonsteroidal Anti-inflammatory Drug

Low-Dose Aspirin for Preeclampsia Prevention (ASAPP Trial)

Phase 3
Waitlist Available
Led By Line Malha, MD, MS
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Renal disease (proteinuria ≥300mg/day or estimated GFR<90mL/min/1.73 m2)
Autoimmune disease (e.g. systemic lupus erythematous, antiphospholipid syndrome)
Must not have
Contraindication to ASA therapy (including but not limited to allergy and high bleeding risk)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months for each patient (from recruitment until 6 weeks postpartum)
Awards & highlights

Summary

This trial is testing whether a higher dose of aspirin can help prevent preeclampsia, a dangerous complication of pregnancy.

Who is the study for?
This trial is for pregnant women over 18, under 16 weeks gestation with a history of preeclampsia or risk factors like chronic hypertension, diabetes, renal disease, or autoimmune disorders. It's not for those allergic to aspirin, at high bleeding risk, with major fetal malformations on ultrasound, or planning pregnancy termination.
What is being tested?
The study compares the effectiveness of two low-dose aspirin regimens (81mg vs. 162mg daily) in preventing severe or preterm preeclampsia in high-risk pregnant women. Participants will be randomly assigned to one of the dosages from a single center.
What are the potential side effects?
Aspirin may cause side effects such as gastrointestinal issues (like stomach pain and heartburn), increased bleeding tendency especially during delivery if taken close to labor onset, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have kidney issues with protein in my urine or low kidney function.
Select...
I have an autoimmune disease like lupus.
Select...
I am pregnant, under 16 weeks, and at risk for preeclampsia.
Select...
I have type 1 or type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot take ASA due to an allergy or high risk of bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months for each patient (from recruitment until 6 weeks postpartum)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for each patient (from recruitment until 6 weeks postpartum) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of preeclampsia with severe features
Incidence of preterm (<37 weeks) preeclampsia
Secondary outcome measures
Aspirin adherence
Aspirin compliance
Maternal and Fetal Outcomes
+1 more
Other outcome measures
Pre-Eclampsia

Trial Design

2Treatment groups
Active Control
Group I: 162mg ASAActive Control1 Intervention
Patients in Arm 2, will be instructed to take two tablets simultaneously orally once per day.
Group II: 81mg ASAActive Control1 Intervention
Patients in Arm 1, will be instructed to take one tablet of 81mg aspirin per day.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,064 Previous Clinical Trials
1,318,786 Total Patients Enrolled
Line Malha, MD, MSPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Acetylsalicylic Acid (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04070573 — Phase 3
Prophylaxis of Preeclampsia Research Study Groups: 162mg ASA, 81mg ASA
Prophylaxis of Preeclampsia Clinical Trial 2023: Acetylsalicylic Acid Highlights & Side Effects. Trial Name: NCT04070573 — Phase 3
Acetylsalicylic Acid (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04070573 — Phase 3
~69 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top